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Objective: To evaluate the diagnostic performance of quantitative fecal immunochemical testing (FIT) and to provide reference for designing effective colorectal cancer (CRC) screening strategy in China. Methods: Based on an ongoing randomized controlled trial comparing the colorectal cancer screening strategies, this current study involved 3 407 participants aged 50-74 years who had undergone colonoscopies. All the feces samples were collected from the participants prior to receiving the colonoscopy. Fecal hemoglobin (Hb) was tested by FIT following a standardized operation process. Diagnosis-related indicators of FIT were calculated using the colonoscopy results as the gold standard. Results: Among the 3 407 participants, the mean age (SD) as 60.5 (6.3) years and 1 753 (51.5%) were males. The participants involved 28 (0.8%) CRCs, 255 (7.5%) advanced adenomas, 677 (19.9%) nonadvanced adenomas, and 2 447 (71.8%) benign or negative findings. With an overall positivity rate of 2.8% (96/3 407) at the recommended cutoff value of 20 μg Hb/g, the sensitivities of FIT for both CRC and advanced adenoma were 57.1% (95 %CI : 37.2%-75.5%) and 11.0% (95 %CI : 7.4%-15.5%), respectively, with the corresponding specificity as 98.4% (95 %CI : 97.8%-98.8%). At a decreased cut-off value of 5 μg Hb/g, the sensitivities for detecting CRC and advanced adenoma increased to 64.3% (95 %CI : 44.1%-81.4%) and 16.5% (95 %CI : 12.1%-21.6%), respectively, but the specificity reduced to 95.2% (95 %CI : 94.4%-95.9%). The areas under the ROC curve for CRC and advanced adenoma were 0.908 (95 %CI : 0.842-0.973) and 0.657 (95 %CI : 0.621-0.692), respectively. Of the diagnostic performance, there were no significant differences noticed by different sex and age groups. Conclusions: In our study, the quantitative FIT showed modest sensitivity in detecting CRC but limited sensitivity in detecting advanced adenoma. In population-based CRC screening programs, the quantitative FIT had the advantage of adjusting the positive threshold based on the targeted detection rate and available resource load of colonoscopy.

Objective: To systematically review the quality and reporting quality of colorectal cancer screening guidelines, and to provide reference for the update of colorectal cancer screening guidelines and colorectal cancer screening in China. Methods: "Colorectal cancer", "colorectal tumor", "screening", "screening", "guide", "consensus", "Colorectal cancer", "Colorectal neoplasms", "Screening", "Early Detection of Cancer", "Guideline" and "recommendation" were used as search keywords. The literature retrieval for all the Chinese and English guidelines published before April 2018 was conducted by using PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, China Biology Medicine disc (CBMdisc), Cochrane Library, Guideline International Network, China Guidelines Clearinghouse (CGC) and the official website of the US Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), International Agency for Research on Cancer (IARC), Australia Cancer Council (ACC) and Association of Coloproctology of Great Britain & Ireland (ACPGBI). The inclusion criteria were independent guidance documents for colorectal cancer screening. The language is limited to Chinese and English. The exclusion criteria were literature on interpretation, evaluation, introduction, etc., as well as the translated version of the guide and old guides. The quality and reporting norms of colorectal cancer screening guidelines were compared and evaluated using the European Guideline Research and Assessment Tool (AGREE Ⅱ) and the Practice Guideline Reporting Standard (RIGHT). Results: A total of 15 guides were included. The results of the AGREE Ⅱ quality evaluation showed that the overall quality of 15 guides was high. Among them, there were 9 guides with an overall score of 50 or more, 10 with a recommendation level of "A", and 2 with a rating of "B". There were 3 guides for "C"; each guide scores higher in scope and purpose, and clarity, and scores vary greatly in the areas of participants, rigor, applicability, and independence. The results of the RIGHT evaluation showed that 15 guides were insufficient in six areas except for background information, evidence, recommendations, reviews and quality assurance, funding and conflict of interest statements and management, and other aspects. Conclusion: The overall quality of included guidelines for colorectal cancer screening is high, but the normative nature needs to be strengthened.